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Compares treatment options for Hysterectomy
Official title Vaginal NOTES Hysterectomy Versus Vaginal Hysterectomy
ClinicalTrials.gov ID: NCT04886791
What this study is testing
- What it's testing
- Rationale: Natural orifice transluminal endoscopic surgery (NOTES) is a minimal invasive technique using the natural body orifices like stomach, oesophagus, bladder, rectum and vagina to access the human body for surgery. In 2012, the first vaginal NOTES (vNOTES) hysterectomy was performed.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Written and orally given informed consent
- 18 years and older
- Native Dutch speaker or in control of the Dutch language in speaking and writing
- Indication for hysterectomy for benign indication
- Possible to perform a VH judged by experienced (resident) gynaecologist during gynaecological examination
You likely can't join if
- Any contra-indication for VH (for example, large uterus myomatosus, not enough descensus, etc) as judged by experienced gynaecologist
- History of more than 1 caesarean section
- History of endometriosis
- History of rectal surgery
- History of pelvic radiation
- Suspected rectovaginal endometriosis
See the full eligibility criteria
- Written and orally given informed consent
- 18 years and older
- Native Dutch speaker or in control of the Dutch language in speaking and writing
- Indication for hysterectomy for benign indication
- Possible to perform a VH judged by experienced (resident) gynaecologist during gynaecological examination
- Any contra-indication for VH (for example, large uterus myomatosus, not enough descensus, etc) as judged by experienced gynaecologist
- History of more than 1 caesarean section
- History of endometriosis
- History of rectal surgery
- History of pelvic radiation
- Suspected rectovaginal endometriosis
- History of pelvic inflammatory disease, especially prior tubo-ovarian or pouch of Douglas abscess or suspected adhesions due to (ruptured) inflammatory disease (for example ruptured appendicitis)
- Virginity
- Pregnancy
- Indication for anterior or posterior colporrhaphy during the same surgery
- Indication of mid urethral slings
- Uterus myomatosus will not be an exclusion criteria but the surgeon will indicate if it is possible to remove the uterus vaginally.
The study team makes the final eligibility decision.
Where it's taking place
- Eindhoven, North Brabant, Netherlands
- Heerlen, North Brabant, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Eindhoven, North Brabant, Netherlands; Heerlen, North Brabant, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.